First 34 U.S. Patients Implanted With Smallest Triple-Chamber CRT Device on the Market—BIOTRONIK's New Evia HF-T Pacemaker

LAKE OSWEGO, Oregon, USA, November 19, 2012—BIOTRONIK, a leading manufacturer of innovative medical technology, announced that high profile medical centers across the country are implanting the new Evia HF-T triple-chamber cardiac resynchronization therapy (CRT) pacemaker.

Immediately following the Food and Drug Administration’s (FDA) approval, BIOTRONIK began delivering the new Evia HF-T devices to medical centers across the U.S. to meet considerable demand for improved therapeutic options for patients. The first 34 patients received devices in the days following device approval by the Food and Drug Administration (FDA), with dozens more scheduled in the following weeks.

Hospitals participating in the initial implantations are located across the country, including:

Evia HF-T offers the company’s revolutionary Closed Loop Stimulation (CLS) technology, the only rate response algorithm that is FDA-approved to respond to exercise and acute mental stress on a beat-to-beat basis.

“For me, this device means my options for using CLS—a therapy that is both much needed and well documented in my clinical practice—are expanded to include patients with heart failure,” said Blair Grubb, MD, from the University of Toledo, Ohio. “Patients in general can—and do—benefit from this unique physiologic rate-adaptive pacing mode, but patients with heart failure may derive unique benefit since adaptive algorithms dependent on physical activity alone may not respond as appropriately.”

“Electrophysiologists ranging from private practice to academic training centers agree that BIOTRONIK’s Evia HF-T offers groundbreaking technology, which makes it an ideal option for patients with heart failure conditions,” said Rex Richmond, Vice President of Marketing at BIOTRONIK Inc. “This unique CRT pacemaker completes BIOTRONIK’s quest to offer a full line of highly competitive products in the United States, Evia HF-T is the only CRT pacemaker to offer all the therapeutic benefits available in competing CRT pacemakers — plus unique technology, such as cellular home monitoring with no cost to the patient.”

He continued, “We’ve been listening to what physicians have been asking for and Evia HF-T is today’s example of a device that fulfills the needs of both patients and physicians, and there are more to come.”

“BIOTRONIK is poised to deliver exactly what is needed at a time of rapid change and increased scrutiny in the world of medicine,” added Richmond. “Moving forward, we’ll continue to focus on why BIOTRONIK is—and has been—the right choice, both now and in the future.”

Monitoring heart failure progression

Increased lung fluid levels can be one indicator of heart failure progression, and BIOTRONIK’s Evia HF-T devices contain the company’s proprietary TI feature, which measures thoracic impedance. The patient’s physician can use this information as additional insight to manage critically important aspects of patient care.

The Evia HF-T system also includes the company’s innovative BIOTRONIK Home Monitoring® technology, which automatically transmits a patient’s clinical and device status on a daily basis—making it readily available to the physician without the need for any patient interaction. BIOTRONIK Home Monitoring® is the industry’s only remote patient management system with FDA-approval for early detection of clinically relevant events. TI is one of nine potentially meaningful heart failure parameters transferred by BIOTRONIK Home Monitoring®. Several parameters allow for customizable alert settings.

About Evia HF-T

Evia HF-T is the smallest CRT pacemaker device currently available, with the most options for physicians to use when treating patients with heart failure conditions. Evia HF-T provides tools to continuously maximize CRT therapy, features to optimize LV thresholds and avoid phrenic nerve stimulation, information to help manage a patient’s heart failure progression, and unique technologies that provide a physiologic rate response.

For more information: www.biotronik.com

Contact U.S.

Rex Richmond

Vice President, Marketing

BIOTRONIK, Inc.

6024 Jean Road

Lake Oswego, OR 97035

(800) 547-0394, Ext. 8222

(503) 451-8222

Email: rex.richmond@biotronik.com

Contact:

Manuela Schildwächter

Communications & PR Manager

BIOTRONIK SE & Co. KG

Woermannkehre 1

12359 Berlin

Tel. 49 (0) 30 68905 1466

Email: manuela.schidwaechter@biotronik.com

About BIOTRONIK SE & Co. KG

As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of more than 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success—and deliver confidence and peace of mind to physicians and their patients worldwide.